Trial Outcomes & Findings for A Trial to Evaluate Efficacy and Safety of Lenvatinib in Combination With Everolimus in Subjects With Unresectable Advanced or Metastatic Non Clear Cell Renal Cell Carcinoma (nccRCC) Who Have Not Received Any Chemotherapy for Advanced Disease (NCT NCT02915783)
NCT ID: NCT02915783
Last Updated: 2023-01-17
Results Overview
ORR was assessed by the investigator based on Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. ORR was defined as the percentage of participants with confirmed best overall response (BOR) of complete response (CR) or partial response (PR). CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to less than (\<) 10 millimeters (mm). PR was defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
41 participants
Primary outcome timeframe
From the date of the first dose of study drug to the date of the first documentation of disease progression or death, whichever occurred first (up to approximately 3 years 9 months)
Results posted on
2023-01-17
Participant Flow
Participants took part in the study at 8 investigative sites in the United States from 20 February 2017 to 2 November 2021.
A total of 41 participants were enrolled (signed inform consent form) and screened, of which 10 were screen failures and 31 participants received the study treatment.
Participant milestones
| Measure |
Lenvatinib 18 mg/Day + Everolimus 5 mg/Day
Participants received initial dose of lenvatinib 18 milligrams per day (mg/day) (one 10-milligram \[mg\] capsule and two 4-mg capsules), orally once daily and initial dose of everolimus 5 mg/day (5-mg tablets), orally once daily in immediate succession approximately at the same time each morning (consistently either with or without food) in 28-day (4-week) cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or discontinuation by sponsor. Lenvatinib dose reduction was permitted from 18 mg/day to 14, 10, and 8 mg/day, and everolimus dose reduction was permitted from 5 mg/day to 5 mg every other day to manage toxicity, when required.
|
|---|---|
|
Overall Study
STARTED
|
31
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
24
|
Reasons for withdrawal
| Measure |
Lenvatinib 18 mg/Day + Everolimus 5 mg/Day
Participants received initial dose of lenvatinib 18 milligrams per day (mg/day) (one 10-milligram \[mg\] capsule and two 4-mg capsules), orally once daily and initial dose of everolimus 5 mg/day (5-mg tablets), orally once daily in immediate succession approximately at the same time each morning (consistently either with or without food) in 28-day (4-week) cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or discontinuation by sponsor. Lenvatinib dose reduction was permitted from 18 mg/day to 14, 10, and 8 mg/day, and everolimus dose reduction was permitted from 5 mg/day to 5 mg every other day to manage toxicity, when required.
|
|---|---|
|
Overall Study
Death
|
21
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
A Trial to Evaluate Efficacy and Safety of Lenvatinib in Combination With Everolimus in Subjects With Unresectable Advanced or Metastatic Non Clear Cell Renal Cell Carcinoma (nccRCC) Who Have Not Received Any Chemotherapy for Advanced Disease
Baseline characteristics by cohort
| Measure |
Lenvatinib 18 mg/Day + Everolimus 5 mg/Day
n=31 Participants
Participants received initial dose of lenvatinib 18 mg/day (one 10-mg capsule and two 4-mg capsules), orally once daily and initial dose of everolimus 5 mg/day (5-mg tablets), orally once daily in immediate succession approximately at the same time each morning (consistently either with or without food) in 28-day (4-week) cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or discontinuation by sponsor. Lenvatinib dose reduction was permitted from 18 mg/day to 14, 10, and 8 mg/day, and everolimus dose reduction was permitted from 5 mg/day to 5 mg every other day to manage toxicity, when required.
|
|---|---|
|
Age, Continuous
|
63.3 years
STANDARD_DEVIATION 12.6 • n=99 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: From the date of the first dose of study drug to the date of the first documentation of disease progression or death, whichever occurred first (up to approximately 3 years 9 months)Population: The FAS included participants who received at least 1 dose of the study drugs.
ORR was assessed by the investigator based on Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. ORR was defined as the percentage of participants with confirmed best overall response (BOR) of complete response (CR) or partial response (PR). CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to less than (\<) 10 millimeters (mm). PR was defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Lenvatinib 18 mg/Day + Everolimus 5 mg/Day
n=31 Participants
Participants received initial dose of lenvatinib 18 mg/day (one 10-mg capsule and two 4-mg capsules), orally once daily and initial dose of everolimus 5 mg/day (5-mg tablets), orally once daily in immediate succession approximately at the same time each morning (consistently either with or without food) in 28-day (4-week) cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or discontinuation by sponsor. Lenvatinib dose reduction was permitted from 18 mg/day to 14, 10, and 8 mg/day, and everolimus dose reduction was permitted from 5 mg/day to 5 mg every other day to manage toxicity, when required.
|
|---|---|
|
Objective Response Rate (ORR)
|
25.8 percentage of participants
Interval 11.9 to 44.6
|
SECONDARY outcome
Timeframe: From the date of the first dose of study drug to the date of the first documentation of disease progression or death, whichever occurred first (up to approximately 3 years 9 months)Population: The FAS included participants who received at least 1 dose of the study drugs.
PFS was assessed by investigator per RECIST v1.1, defined as time from date of first dose of study drug to date of first documentation of progressive disease (PD) or death whichever occurred first. PD: greater than or equal to (\>=) 20% increase in sum of diameters of target lesions, reference-smallest sum recorded in study (sum at baseline if that was smallest). Sum of diameters must have absolute increase of \>=5 mm. Appearance of \>=1 new lesions also considered PD. PFS was analyzed using Kaplan Meier method. PFS was censored on date of last adequate radiologic assessment prior to new anticancer therapy, more than one missed visits, treatment discontinuation, and cutoff date when no PD or death occurred before any of these (on first dose of study treatment if no adequate post baseline tumor assessment was available), per publication by Food and Drug Administration (FDA) 'Guidance for Industry Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics (2007).
Outcome measures
| Measure |
Lenvatinib 18 mg/Day + Everolimus 5 mg/Day
n=31 Participants
Participants received initial dose of lenvatinib 18 mg/day (one 10-mg capsule and two 4-mg capsules), orally once daily and initial dose of everolimus 5 mg/day (5-mg tablets), orally once daily in immediate succession approximately at the same time each morning (consistently either with or without food) in 28-day (4-week) cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or discontinuation by sponsor. Lenvatinib dose reduction was permitted from 18 mg/day to 14, 10, and 8 mg/day, and everolimus dose reduction was permitted from 5 mg/day to 5 mg every other day to manage toxicity, when required.
|
|---|---|
|
Progression-free Survival (PFS)
|
13.11 months
Interval 5.49 to 24.21
|
SECONDARY outcome
Timeframe: From the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)Population: The FAS included participants who received at least 1 dose of the study drugs.
OS was defined as the time from the date of the first dose of study drug until the date of death from any cause. OS was analyzed using Kaplan Meier method. In the absence of death before data cutoff, participants were censored either at the date last known to be alive or the date of data cutoff, whichever came earlier. Participants were followed for survival every 12 weeks after the end of treatment visit. If a clinic visit was not feasible, follow-up information was obtained via telephone or email.
Outcome measures
| Measure |
Lenvatinib 18 mg/Day + Everolimus 5 mg/Day
n=31 Participants
Participants received initial dose of lenvatinib 18 mg/day (one 10-mg capsule and two 4-mg capsules), orally once daily and initial dose of everolimus 5 mg/day (5-mg tablets), orally once daily in immediate succession approximately at the same time each morning (consistently either with or without food) in 28-day (4-week) cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or discontinuation by sponsor. Lenvatinib dose reduction was permitted from 18 mg/day to 14, 10, and 8 mg/day, and everolimus dose reduction was permitted from 5 mg/day to 5 mg every other day to manage toxicity, when required.
|
|---|---|
|
Overall Survival (OS)
|
16.33 months
Interval 9.23 to 33.22
|
Adverse Events
Lenvatinib 18 mg/Day + Everolimus 5 mg/Day
Serious events: 12 serious events
Other events: 31 other events
Deaths: 21 deaths
Serious adverse events
| Measure |
Lenvatinib 18 mg/Day + Everolimus 5 mg/Day
n=31 participants at risk
Participants received initial dose of lenvatinib 18 mg/day (one 10-mg capsule and two 4-mg capsules), orally once daily and initial dose of everolimus 5 mg/day (5-mg tablets), orally once daily in immediate succession approximately at the same time each morning (consistently either with or without food) in 28-day (4-week) cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or discontinuation by sponsor. Lenvatinib dose reduction was permitted from 18 mg/day to 14, 10, and 8 mg/day, and everolimus dose reduction was permitted from 5 mg/day to 5 mg every other day to manage toxicity, when required.
|
|---|---|
|
Cardiac disorders
Cardiac arrest
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Cardiac disorders
Cardiac failure
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Gastrointestinal disorders
Diarrhoea
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Gastrointestinal disorders
Faecaloma
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Gastrointestinal disorders
Gastric ulcer
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Gastrointestinal disorders
Haematochezia
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Gastrointestinal disorders
Intestinal obstruction
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Gastrointestinal disorders
Nausea
|
9.7%
3/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Gastrointestinal disorders
Vomiting
|
9.7%
3/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
General disorders
Non-cardiac chest pain
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
General disorders
Pyrexia
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Infections and infestations
Pneumonia
|
6.5%
2/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Injury, poisoning and procedural complications
Fall
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Investigations
International normalised ratio increased
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
6.5%
2/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant ascites
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
6.5%
2/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Nervous system disorders
Dizziness
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Nervous system disorders
Hepatic encephalopathy
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Renal and urinary disorders
Acute kidney injury
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Cardiac disorders
Angina pectoris
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Infections and infestations
Sepsis
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Nervous system disorders
Cerebrovascular accident
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
Other adverse events
| Measure |
Lenvatinib 18 mg/Day + Everolimus 5 mg/Day
n=31 participants at risk
Participants received initial dose of lenvatinib 18 mg/day (one 10-mg capsule and two 4-mg capsules), orally once daily and initial dose of everolimus 5 mg/day (5-mg tablets), orally once daily in immediate succession approximately at the same time each morning (consistently either with or without food) in 28-day (4-week) cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or discontinuation by sponsor. Lenvatinib dose reduction was permitted from 18 mg/day to 14, 10, and 8 mg/day, and everolimus dose reduction was permitted from 5 mg/day to 5 mg every other day to manage toxicity, when required.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
12.9%
4/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
9.7%
3/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Cardiac disorders
Atrial fibrillation
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Cardiac disorders
Atrial tachycardia
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Cardiac disorders
Cardiac failure
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Cardiac disorders
Cyanosis
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Cardiac disorders
Palpitations
|
6.5%
2/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Cardiac disorders
Stress cardiomyopathy
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Ear and labyrinth disorders
External ear pain
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Ear and labyrinth disorders
Tinnitus
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Endocrine disorders
Hyperthyroidism
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Endocrine disorders
Hypothyroidism
|
19.4%
6/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Eye disorders
Dry eye
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Eye disorders
Eye swelling
|
9.7%
3/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Eye disorders
Vision blurred
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Gastrointestinal disorders
Abdominal discomfort
|
6.5%
2/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Gastrointestinal disorders
Abdominal distension
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Gastrointestinal disorders
Abdominal pain
|
29.0%
9/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Gastrointestinal disorders
Abdominal pain lower
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
12.9%
4/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Gastrointestinal disorders
Anal fissure
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Gastrointestinal disorders
Constipation
|
19.4%
6/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Gastrointestinal disorders
Diarrhoea
|
58.1%
18/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Gastrointestinal disorders
Dry mouth
|
12.9%
4/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Gastrointestinal disorders
Dyspepsia
|
19.4%
6/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Gastrointestinal disorders
Flatulence
|
6.5%
2/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
12.9%
4/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Gastrointestinal disorders
Glossodynia
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Gastrointestinal disorders
Haematochezia
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Gastrointestinal disorders
Lip pain
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Gastrointestinal disorders
Nausea
|
58.1%
18/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Gastrointestinal disorders
Odynophagia
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Gastrointestinal disorders
Oral dysaesthesia
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Gastrointestinal disorders
Oral pain
|
12.9%
4/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Gastrointestinal disorders
Retching
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Gastrointestinal disorders
Stomatitis
|
38.7%
12/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Gastrointestinal disorders
Toothache
|
12.9%
4/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Gastrointestinal disorders
Vomiting
|
51.6%
16/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
General disorders
Asthenia
|
12.9%
4/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
General disorders
Chest discomfort
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
General disorders
Chills
|
6.5%
2/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
General disorders
Crepitations
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
General disorders
Facial pain
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
General disorders
Fatigue
|
71.0%
22/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
General disorders
Influenza like illness
|
9.7%
3/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
General disorders
Non-cardiac chest pain
|
6.5%
2/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
General disorders
Oedema peripheral
|
16.1%
5/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
General disorders
Pain
|
9.7%
3/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
General disorders
Peripheral swelling
|
9.7%
3/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
General disorders
Pyrexia
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Infections and infestations
Bronchitis
|
6.5%
2/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Infections and infestations
Ear infection
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Infections and infestations
Eye infection
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Infections and infestations
Folliculitis
|
6.5%
2/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Infections and infestations
Furuncle
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Infections and infestations
Gastroenteritis viral
|
6.5%
2/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Infections and infestations
Infection
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Infections and infestations
Nasopharyngitis
|
6.5%
2/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Infections and infestations
Pneumonia
|
6.5%
2/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Infections and infestations
Respiratory syncytial virus infection
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Infections and infestations
Sinusitis
|
12.9%
4/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Infections and infestations
Tooth abscess
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Infections and infestations
Upper respiratory tract infection
|
6.5%
2/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Infections and infestations
Urinary tract infection
|
9.7%
3/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Injury, poisoning and procedural complications
Contusion
|
6.5%
2/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Injury, poisoning and procedural complications
Fall
|
9.7%
3/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Injury, poisoning and procedural complications
Rib fracture
|
6.5%
2/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Investigations
Alanine aminotransferase increased
|
9.7%
3/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Investigations
Amylase increased
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Investigations
Aspartate aminotransferase abnormal
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Investigations
Aspartate aminotransferase increased
|
6.5%
2/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Investigations
Blood alkaline phosphatase increased
|
6.5%
2/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Investigations
Blood cholesterol increased
|
9.7%
3/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Investigations
Blood creatinine increased
|
19.4%
6/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Investigations
Blood lactate dehydrogenase increased
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Investigations
Blood potassium decreased
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Investigations
Blood thyroid stimulating hormone increased
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Investigations
Blood triglycerides increased
|
9.7%
3/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Investigations
Blood urea increased
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Investigations
Heart sounds abnormal
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Investigations
Lipase increased
|
9.7%
3/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Investigations
Neutrophil count decreased
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Investigations
Platelet count decreased
|
12.9%
4/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Investigations
Platelet count increased
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Investigations
Specific gravity urine increased
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Investigations
Vitamin D decreased
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Investigations
Weight decreased
|
38.7%
12/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
54.8%
17/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Metabolism and nutrition disorders
Dehydration
|
12.9%
4/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Metabolism and nutrition disorders
Fluid retention
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
12.9%
4/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
6.5%
2/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
12.9%
4/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
12.9%
4/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
6.5%
2/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
6.5%
2/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.8%
8/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
19.4%
6/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.5%
2/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
16.1%
5/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
16.1%
5/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.5%
2/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.5%
2/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.1%
5/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
6.5%
2/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant ascites
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
9.7%
3/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Nervous system disorders
Balance disorder
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Nervous system disorders
Carpal tunnel syndrome
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Nervous system disorders
Cerebral haematoma
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Nervous system disorders
Dizziness
|
12.9%
4/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Nervous system disorders
Dizziness postural
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Nervous system disorders
Dysgeusia
|
12.9%
4/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Nervous system disorders
Headache
|
25.8%
8/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Nervous system disorders
Hepatic encephalopathy
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Nervous system disorders
Hypoaesthesia
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Nervous system disorders
Irregular sleep wake rhythm disorder
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Nervous system disorders
Memory impairment
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
9.7%
3/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Nervous system disorders
Radicular pain
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Nervous system disorders
Sciatica
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Nervous system disorders
Taste disorder
|
6.5%
2/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Nervous system disorders
Tremor
|
6.5%
2/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Nervous system disorders
Ulnar nerve palsy
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Psychiatric disorders
Anxiety
|
22.6%
7/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Psychiatric disorders
Confusional state
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Psychiatric disorders
Depression
|
9.7%
3/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Psychiatric disorders
Hallucination
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Psychiatric disorders
Insomnia
|
25.8%
8/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Renal and urinary disorders
Acute kidney injury
|
6.5%
2/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Renal and urinary disorders
Dysuria
|
6.5%
2/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Renal and urinary disorders
Haematuria
|
9.7%
3/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Renal and urinary disorders
Nocturia
|
6.5%
2/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Renal and urinary disorders
Pollakiuria
|
6.5%
2/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Renal and urinary disorders
Proteinuria
|
29.0%
9/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Renal and urinary disorders
Renal pain
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Renal and urinary disorders
Urinary retention
|
6.5%
2/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Reproductive system and breast disorders
Vaginal discharge
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
19.4%
6/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
22.6%
7/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
29.0%
9/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
25.8%
8/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
6.5%
2/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
19.4%
6/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
12.9%
4/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
9.7%
3/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
9.7%
3/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary pain
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Respiratory, thoracic and mediastinal disorders
Respiration abnormal
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
9.7%
3/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
6.5%
2/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
9.7%
3/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Skin and subcutaneous tissue disorders
Blister
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
9.7%
3/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.5%
2/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
12.9%
4/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.1%
5/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.7%
3/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
6.5%
2/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Skin and subcutaneous tissue disorders
Sensitive skin
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
6.5%
2/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Skin and subcutaneous tissue disorders
Skin toxicity
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
6.5%
2/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Vascular disorders
Flushing
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Vascular disorders
Hot flush
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Vascular disorders
Hypertension
|
32.3%
10/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Vascular disorders
Hypotension
|
12.9%
4/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Vascular disorders
Jugular vein thrombosis
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Vascular disorders
Vena cava thrombosis
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Cardiac disorders
Cardiac failure congestive
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Ear and labyrinth disorders
Hypoacusis
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Gastrointestinal disorders
Abdominal tenderness
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Gastrointestinal disorders
Gastrointestinal toxicity
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Infections and infestations
Asymptomatic bacteriuria
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Infections and infestations
Impetigo
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Infections and infestations
Injection site abscess
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Infections and infestations
Tooth infection
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Investigations
Lipids increased
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Investigations
White blood cell count decreased
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Vascular disorders
Deep vein thrombosis
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Nervous system disorders
Paraesthesia
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
3.2%
1/31 • Serious and non-serious adverse events are reported from the first dose of study drug up to 28 days following last dose of study drug, or until resolution of adverse event, whichever occurred first (up to approximately 3 years 10 months) and as planned All-cause mortality is reported from the date of the first dose of study drug until the date of death from any cause (up to approximately 4 years 8 months)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place